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1. (WO2018010815) FORMULATION FOR ADMINISTRATION OF RNA
Latest bibliographic data on file with the International Bureau   

Pub. No.: WO/2018/010815 International Application No.: PCT/EP2016/066930
Publication Date: 18.01.2018 International Filing Date: 15.07.2016
IPC:
A61K 9/00 (2006.01) ,C12N 15/87 (2006.01)
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9
Medicinal preparations characterised by special physical form
C CHEMISTRY; METALLURGY
12
BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
N
MICRO-ORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICRO-ORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
15
Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
09
Recombinant DNA-technology
87
Introduction of foreign genetic material using processes not otherwise provided for, e.g. co-transformation
Applicants:
BIONTECH RNA PHARMACEUTICALS GMBH [DE/DE]; An der Goldgrube 12 55131 Mainz, DE
TRON - TRANSLATIONALE ONKOLOGIE AN DER UNIVERSITÄTSMEDIZIN DER JOHANNES GUTENBERG-UNIVERSITÄT MAINZ GGMBH [DE/DE]; Freiligrathstrasse 12 55131 Mainz, DE
Inventors:
SAHIN, Ugur; DE
HAAS, Heinrich; DE
VOGEL, Annette; DE
ZUCKER, Daniel; DE
ERBAR, Stephanie; DE
REUTER, Kerstin; DE
SCHLEGEL, Anne; DE
HÖRNER, Sebastian; DE
KREITER, Sebastian; DE
DIKEN, Mustafa; DE
Agent:
MÜLLER, Christian; DE
Priority Data:
Title (EN) FORMULATION FOR ADMINISTRATION OF RNA
(FR) FORMULE POUR L'ADMINISTRATION D'ARN.
Abstract:
(EN) The present invention relates to compositions comprising polyplex formulations for delivery of RNA to a target organ or a target cell after parenteral administration, in particular after intramuscular administration. More precisely, the present invention relates to formulations for administration of RNA such as self-replicating RNA, in particular by intramuscular injection. In more detail, the formulations comprise polyplex particles from single stranded RNA and a polyalkyleneimine. The RNA may encode a protein of interest, such as a pharmaceutically active protein. Furthermore, the present invention relates to pharmaceutical products, comprising said RNA polyplex formulations for parenteral application to humans or to animals. The present invention relates as well to manufacturing of such pharmaceutical products, comprising, optionally, steps of sterile filtration, freezing and dehydration.
(FR) Les composés comprennent des polyplexes pour l'administration de l'ARN à un organe cible, ou à une cellule cible après administration parentérale et intramusculaire. Plus précisément, l'invention porte sur des formules pour l'administration d'ARN, tel qu'un ARN auto-répliquant par injection intramusculaire. Plus particulièrement, les formulations comprennent des particules polyplexes provenant d'un ARN monocaténaire et d'une polyalkylèneimine. L'ARN peut coder une protéine d'intérêt, telle qu'une protéine pharmaceutiquement active. L'invention porte sur les produits pharmaceutiques, comprenant les formulations de polyplexes d'ARN pour une application parentérale à des humains ou à des animaux. La fabrication de ces produits pharmaceutiques, comprenant les étapes de filtration, de congélation et de déshydratation stériles.
Designated States: AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW
African Regional Intellectual Property Organization (ARIPO) (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Office (AM, AZ, BY, KG, KZ, RU, TJ, TM)
European Patent Office (EPO) (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG)
Publication Language: English (EN)
Filing Language: English (EN)